Uncinate process support for ethmoid infundibulum illumination

ABSTRACT

A dilation apparatus comprises an elongate member and a dilation assembly that is slidable along the elongate member. The dilation assembly comprises a platform and an inflatable dilator. The platform and the elongate member cooperate to absorb inflation forces from the dilator directed toward the longitudinal axis of the elongate member, such that the dilation forces are exerted against tissue asymmetrically relative to the longitudinal axis of the elongate member. The dilation apparatus may be used to dilate the ethmoid infundibulum in a human patient. Various devices may be used to maintain the dilated state of an ethmoid infundibulum, including a wedge, a mesh, and a tether. An illuminator may be configured to reach around an uncinate process, retract the uncinate process, and then illuminate the ethmoid infundibulum to provide improved visualization of the ethmoid infundibulum.

PRIORITY

This application is a continuation-in-part of U.S. patent applicationSer. No. 13/832,167, entitled “Uncinate Process Support for EthmoidInfundibulum Illumination,” filed Mar. 15, 2013, the disclosure of whichis incorporated by reference herein.

BACKGROUND

In some instances, it may be desirable to dilate an anatomicalpassageway in a patient. This may include dilation of ostia of paranasalsinuses (e.g., to treat sinusitis), dilation of the larynx, dilation ofthe Eustachian tube, dilation of other passageways within the ear, nose,or throat, etc. One method of dilating anatomical passageways includesusing a guidewire and catheter to position an inflatable balloon withinthe anatomical passageway, then inflating the balloon with a fluid(e.g., saline) to dilate the anatomical passageway. For instance, theexpandable balloon may be positioned within an ostium at a paranasalsinus and then be inflated, to thereby dilate the ostium by remodelingthe bone adjacent to the ostium, without requiring incision of themucosa or removal of any bone. The dilated ostium may then allow forimproved drainage from and ventilation of the affected paranasal sinus.A system that may be used to perform such procedures may be provided inaccordance with the teachings of U.S. Pub. No. 2011/0004057, entitled“Systems and Methods for Transnasal Dilation of Passageways in the Ear,Nose or Throat,” published Jan. 6, 2011, the disclosure of which isincorporated by reference herein. An example of such a system is theRelieva® Spin Balloon Sinuplasty™ System by Acclarent, Inc. of MenloPark, Calif.

A variable direction view endoscope may be used with such a system toprovide visualization within the anatomical passageway (e.g., the ear,nose, throat, paranasal sinuses, etc.) to position the balloon atdesired locations. A variable direction view endoscope may enableviewing along a variety of transverse viewing angles without having toflex the shaft of the endoscope within the anatomical passageway. Suchan endoscope that may be provided in accordance with the teachings ofU.S. Pub. No. 2010/0030031, entitled “Swing Prism Endoscope,” publishedFeb. 4, 2010, the disclosure of which is incorporated by referenceherein. An example of such an endoscope is the Acclarent Cyclops™Multi-Angle Endoscope by Acclarent, Inc. of Menlo Park, Calif.

While a variable direction view endoscope may be used to providevisualization within the anatomical passageway, it may also be desirableto provide additional visual confirmation of the proper positioning ofthe balloon before inflating the balloon. This may be done using anilluminating guidewire. Such a guidewire may be positioned within thetarget area and then illuminated, with light projecting from the distalend of the guidewire. This light may illuminate the adjacent tissue andthus be visible to the naked eye from outside the patient throughtranscutaneous illumination. For instance, when the distal end ispositioned in the maxillary sinus, the light may be visible through thepatient's cheek. Using such external visualization to confirm theposition of the guidewire, the balloon may then be advanced distallyalong the guidewire into position at the dilation site. Such anilluminating guidewire may be provided in accordance with the teachingsof U.S. Pub. No. 2012/0078118, entitled “Sinus Illumination LightwireDevice,” published Mar. 29, 2012, the disclosure of which isincorporated by reference herein. An example of such an illuminatingguidewire is the Relieva Luma Sentry™ Sinus Illumination System byAcclarent, Inc. of Menlo Park, Calif.

While several instruments and procedures have been made and used for theear, nose, and throat, it is believed that no one prior to the inventorshas made or used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1 depicts a side elevational view of an exemplary dilation cathetersystem:

FIG. 2 depicts a side elevational view of an exemplary illuminatingguidewire suitable for use with the dilation catheter system of FIG. 1;

FIG. 3 depicts a side cross-sectional view of the illuminating guidewireof FIG. 2;

FIG. 4 depicts a perspective view of an exemplary endoscope suitable foruse with the dilation catheter system of FIG. 1;

FIG. 5 depicts a side elevational view of the distal end of theendoscope of FIG. 5, showing an exemplary range of viewing angles;

FIG. 6 depicts a coronal cross-sectional view of a portion of a nasalcavity, showing portions of the nasal septum, middle turbinate, ethmoidbulla, uncinate process, and ostium of a maxillary sinus;

FIG. 7 depicts a side elevational view of an exemplary infundibularprobe and dilator,

FIG. 8A depicts a coronal cross-sectional view of the portion of thenasal cavity depicted in FIG. 6, with the probe positioned in theinfundibular space and with the dilator in a dilated state:

FIG. 8B depicts a coronal cross-sectional view of the portion of thenasal cavity depicted in FIG. 6, with the uncinate process remodeled todilate the infundibular space;

FIG. 9A depicts a side elevational view of an exemplary dilator devicewith a single sided balloon, with the balloon in a retracted andnon-inflated state;

FIG. 9B depicts a side elevational view of the dilator device of FIG.9A, with the balloon in an extended and inflated state;

FIG. 10A depicts a cross-sectional view of the dilator device of FIG.9A, taken along line 10A-10A of FIG. 9A;

FIG. 10B depicts a cross-sectional view of the dilator device of FIG.9A, taken along line 10B-10B of FIG. 9B

FIG. 11 depicts a side elevational view of an exemplary dilation devicewith an asymmetric sinus dilation balloon;

FIG. 12 depicts a detailed side elevational view of the asymmetric sinusdilation balloon of FIG. 11, with the balloon in a non-inflated state;

FIG. 13 depicts a detailed side elevational view of the distal end ofthe dilation device of FIG. 11, with the balloon in a distallypositioned and inflated state;

FIG. 14 depicts a cross-sectional view of the dilation device of FIG.11, with the balloon in a distally positioned and inflated state, thecross-section taken along line 14-14 of FIG. 13;

FIG. 15 depicts a perspective view of the distal end of dilation deviceof FIG. 11, with the balloon in a distally positioned and inflatedstate;

FIG. 16 depicts a side elevational view of the dilation device of FIG.11, with the balloon in a distally positioned and inflated state;

FIG. 17 depicts a coronal cross-sectional view of the portion of thenasal cavity depicted in FIG. 6, with an exemplary uncinate processsupport positioned to maintain the uncinate process in the remodeledposition of FIG. 8B;

FIG. 18 depicts a coronal cross-sectional view of the portion of thenasal cavity depicted in FIG. 6, with another exemplary uncinate processsupport positioned to maintain the uncinate process in the remodeledposition of FIG. 8B;

FIG. 19 depicts a coronal cross-sectional view of the portion of thenasal cavity depicted in FIG. 6, with another exemplary uncinate processsupport positioned to maintain the uncinate process in the remodeledposition of FIG. 8B;

FIG. 20 depicts a coronal cross-sectional view of the portion of thenasal cavity depicted in FIG. 6, with another exemplary uncinate processsupport positioned to maintain the uncinate process in the remodeledposition of FIG. 8B;

FIG. 21A depicts a side elevational view of an exemplary infundibularilluminating device, with an illuminating wire in a retracted position;and

FIG. 21B depicts a side elevational view of the infundibularilluminating device of FIG. 21A, with the illuminating wire in anextended position.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the technology shouldnot be used to limit its scope. Other examples, features, aspects,embodiments, and advantages of the technology will become apparent tothose skilled in the art from the following description, which is by wayof illustration, one of the best modes contemplated for carrying out thetechnology. As will be realized, the technology described herein iscapable of other different and obvious aspects, all without departingfrom the technology. Accordingly, the drawings and descriptions shouldbe regarded as illustrative in nature and not restrictive.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece assembly.Thus, an end effector is distal with respect to the more proximalhandpiece assembly. It will be further appreciated that, for convenienceand clarity, spatial terms such as “top” and “bottom” also are usedherein with respect to the clinician gripping the handpiece assembly.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

It is further understood that any one or more of the teachings,expressions, versions, examples, etc. described herein may be combinedwith any one or more of the other teachings, expressions, versions,examples, etc. that are described herein. The following-describedteachings, expressions, versions, examples, etc. should therefore not beviewed in isolation relative to each other. Various suitable ways inwhich the teachings herein may be combined will be readily apparent tothose of ordinary skill in the art in view of the teachings herein. Suchmodifications and variations are intended to be included within thescope of the claims.

I. Overview of Exemplary Dilation Catheter System

FIG. 1 shows an exemplary dilation catheter system (10) that may be usedto dilate the ostium of a paranasal sinus; or to dilate some otheranatomical passageway (e.g., within the ear, nose, or throat, etc.).Dilation catheter system (10) of this example comprises a dilationcatheter (20), a guide catheter (30), an inflator (40), and a guidewire(50). By way of example only, dilation catheter system (10) may beconfigured in accordance with at least some of the teachings of U.S.Patent Pub. No. 2011/0004057, the disclosure of which is incorporated byreference herein. In some versions, at least part of dilation cathetersystem (10) is configured similar to the Relieva® Spin BalloonSinuplasty™ System by Acclarent, Inc. of Menlo Park, Calif.

The distal end of dilation catheter (20) includes an inflatable dilator(22). The proximal end of dilation catheter (20) includes a grip (24),which has a lateral port (26) and an open proximal end (28). Dilationcatheter (20) includes a first lumen (not shown) that provides fluidcommunication between lateral port (26) and the interior of dilator(22). Dilator catheter (20) also includes a second lumen (not shown)that extends from open proximal end (28) to an open distal end that isdistal to dilator (22). This second lumen is configured to slidablyreceive guidewire (50). The first and second lumens of dilator catheter(20) are fluidly isolated from each other. Thus, dilator (22) may beselectively inflated and deflated by communicating fluid along the firstlumen via lateral port (26) while guidewire (50) is positioned withinthe second lumen. In some versions, dilator catheter (20) is configuredsimilar to the Relieva Ultirra™ Sinus Balloon Catheter by Acclarent,Inc. of Menlo Park, Calif. In some other versions, dilator catheter (20)is configured similar to the Relieva Solo Pro™ Sinus Balloon Catheter byAcclarent, Inc. of Menlo Park, Calif. Other suitable forms that dilatorcatheter (20) may take will be apparent to those of ordinary skill inthe art in view of the teachings herein.

Guide catheter (30) of the present example includes a bent distal end(32) and a grip (34) at its proximal end. Grip (34) has an open proximalend (36). Guide catheter (30) defines a lumen that is configured toslidably receive catheter (20), such that guide catheter (30) may guidedilator (22) out through bent distal end (32). In some versions, guidecatheter (30) is configured similar to the Relieva Flex™ Sinus GuideCatheter by Acclarent, Inc. of Menlo Park, Calif. Other suitable formsthat guide catheter (30) may take will be apparent to those of ordinaryskill in the art in view of the teachings herein.

Inflator (40) of the present example comprises a barrel (42) that isconfigured to hold fluid and a plunger (44) that is configured toreciprocate relative to barrel (42) to selectively discharge fluid from(or draw fluid into) barrel (42). Barrel (42) is fluidly coupled withlateral port (26) via a flexible tube (46). Thus, inflator (40) isoperable to add fluid to dilator (22) or withdraw fluid from dilator(22) by translating plunger (44) relative to barrel (42). In the presentexample, the fluid communicated by inflator (40) comprises saline,though it should be understood that any other suitable fluid may beused. In some versions, inflator (40) is configured in accordance withat least some of the teachings of U.S. Pat. App. No. 61/725,523,entitled “Inflator for Dilation of Anatomical Passageway,” filed Nov.13, 2012, the disclosure of which is incorporated by reference herein.Other suitable forms that inflator (40) may take will be apparent tothose of ordinary skill in the art in view of the teachings herein.

As best seen in FIGS. 2-3, guidewire (50) of the present examplecomprises a coil (52) positioned about a core wire (54). An illuminationwire (56) extends along the interior of core wire (54) and terminates inan atraumatic lens (58). A connector (55) at the proximal end ofguidewire (50) enables optical coupling between illumination wire (56)and a light source (not shown). Illumination wire (56) may comprise oneor more optical fibers. Lens (58) is configured to project light whenillumination wire (56) is illuminated by the light source, such thatillumination wire (56) transmits light from the light source to the lens(58). In some versions, the distal end of guidewire (50) is moreflexible than the proximal end of guidewire (50). Guidewire (50) has alength enabling the distal end of guidewire (50) to be positioned distalto dilator (22) while the proximal end of guidewire (50) is positionedproximal to grip (24). Guidewire (50) may include indicia along at leastpart of its length (e.g., the proximal portion) to provide the operatorwith visual feedback indicating the depth of insertion of guidewire (50)relative to dilation catheter (20). By way of example only, guidewire(50) may be configured in accordance with at least some of the teachingsof U.S. Pub. No. 2012/0078118, the disclosure of which is incorporatedby reference herein. In some versions, guidewire (50) is configuredsimilar to the Relieva Luma Sentry™ Sinus Illumination System byAcclarent, Inc. of Menlo Park, Calif. Other suitable forms thatguidewire (50) may take will be apparent to those of ordinary skill inthe art in view of the teachings herein.

In an exemplary dilation procedure, guide catheter (30) may first bepositioned near the targeted anatomical passageway, such as a sinusostium (0). Dilator (22) and the distal end of guidewire (50) may bepositioned within or proximal to bent distal end (32) of guide catheter(30) at this stage. Guide catheter (30) is initially inserted into thenose of the patient and is advanced to a position that is within or nearthe ostium (0) to be dilated. This positioning of guide catheter (30)may be performed under visualization provided by an endoscope such asendoscope (60) described below. After guide catheter (30) has beenpositioned, the operator may advance guidewire (50) distally throughguide catheter (30) such that a distal portion of the guidewire (50)passes through the sinus ostium (0) and into the sinus cavity. Theoperator may illuminate illumination wire (56) and lens (58), which mayprovide transcutaneous illumination through the patient's face to enablethe operator to visually confirm positioning of the distal end ofguidewire (50) with relative ease.

With guide catheter (30) and guidewire (50) suitably positioned,dilation catheter (20) is advanced along guidewire (50) and through bentdistal end (32) of guide catheter (30), with dilator (22) in anon-dilated state until dilator (22) is positioned within the sinusostium (0) (or some other targeted anatomical passageway). After dilator(22) has been positioned within the ostium (0), dilator (22) may beinflated, thereby dilating the ostium. To inflate dilator (22), plunger(44) may be actuated to push saline from barrel (42) of inflator (40)through dilation catheter (20) into dilator (22). The transfer of fluidexpands dilator (22) to an expanded state to open or dilate the ostium(0), such as by remodeling the bone, etc., forming ostium (0). By way ofexample only, dilator (22) may be inflated to a volume sized to achieveabout 10 to about 12 atmospheres. Dilator (22) may be held at thisvolume for a few seconds to sufficiently open the ostium (0) (or othertargeted anatomical passageway). Dilator (22) may then be returned to anon-expanded state by reversing plunger (44) of inflator (40) to bringthe saline back to inflator (40). Dilator (22) may be repeatedlyinflated and deflated in different ostia and/or other targetedanatomical passageways. Thereafter, dilation catheter (20), guidewire(50), and guide catheter (30) may be removed from the patient.

II. Overview of Exemplary Endoscope

As noted above, an endoscope (60) may be used to provide visualizationwithin an anatomical passageway (e.g., within the nasal cavity, etc.)during a process of using dilation catheter system (10). As shown inFIGS. 4-5, endoscope of the present example comprises a body (62) and arigid shaft (64) extending distally from body (62). The distal end ofshaft (64) includes a curved transparent window (66). A plurality of rodlenses and light transmitting fibers may extend along the length ofshaft (64). A lens is positioned at the distal end of the rod lenses anda swing prism is positioned between the lens and window (66). The swingprism is pivotable about an axis that is transverse to the longitudinalaxis of shaft (64). The swing prism defines a line of sight that pivotswith the swing prism. The line of sight defines a viewing angle relativeto the longitudinal axis of shaft (64). This line of sight may pivotfrom approximately 0 degrees to approximately 120 degrees, fromapproximately 10 degrees to approximately 90 degrees, or within anyother suitable range. The swing prism and window (66) also provide afield of view spanning approximately 60 degrees (with the line of sightcentered in the field of view). Thus, the field of view enables aviewing range spanning approximately 180 degrees, approximately 140degrees, or any other range, based on the pivot range of the swingprism. Of course, all of these values are mere examples.

Body (62) of the present example includes a light post (70), an eyepiece(72), a rotation dial (74), and a pivot dial (76). Light post (70) is incommunication with the light transmitting fibers in shaft (64) and isconfigured to couple with a source of light, to thereby illuminate thesite in the patient distal to window (66). Eyepiece (72) is configuredto provide visualization of the view captured through window (66) viathe optics of endoscope (60). It should be understood that avisualization system (e.g., camera and display screen, etc.) may becoupled with eyepiece (72) to provide visualization of the view capturedthrough window (66) via the optics of endoscope (60). Rotation dial (74)is configured to rotate shaft (64) relative to body (62) about thelongitudinal axis of shaft (64). It should be understood that suchrotation may be carried out even while the swing prism is pivoted suchthat the line of sight is non-parallel with the longitudinal axis ofshaft (64). Pivot dial (76) is coupled with the swing prism and isthereby operable to pivot the swing prism about the transverse pivotaxis. Indicia (78) on body (62) provide visual feedback indicating theviewing angle. Various suitable components and arrangements that may beused to couple rotation dial (74) with the swing prism will be apparentto those of ordinary skill in the art in view of the teachings herein.By way of example only, endoscope (60) may be configured in accordancewith at least some of the teachings of U.S. Pub. No. 2010/0030031, thedisclosure of which is incorporated by reference herein. In someversions, endoscope (60) is configured similar to the Acclarent Cyclops™Multi-Angle Endoscope by Acclarent, Inc. of Menlo Park, Calif. Othersuitable forms that endoscope (60) may take will be apparent to those ofordinary skill in the art in view of the teachings herein.

III. Exemplary Dilation of the Ethmoid infundibulum

FIG. 6 shows a coronal cross-sectional view of a left portion of apatient's nasal cavity. In particular, FIG. 6 shows the nasal septum(NS), the middle turbinate (MT) lateral to the nasal septum (NS), andthe uncinate process (UP) and ethmoid bulla (B) lateral to the middleturbinate (MT). The uncinate process (UP) and the ethmoid bulla (B)together define the ethmoid infundibulum (EI), which is a transitionspace leading to the maxillary ostium (MO). The maxillary ostium (MO)provides a passageway between the ethmoid infundibulum (EI) and themaxillary sinus (not shown).

In some instances, it may be desirable to use dilation catheter system(10) to dilate the maxillary ostium (MO) of a patient or to otherwisereach the maxillary ostium (MO). However, the uncinate process (UP) maymake it difficult to visualize and reach the maxillary ostium (MO). Itmay therefore be desirable to at least temporarily move the uncinateprocess (UP), to thereby dilate the ethmoid infundibulum (EI) andimprove access to (and visualization of) the maxillary ostium (MO).Since the uncinate process (UP) is a fragile structure, a balloon may beused to gently move the uncinate process (UP) since a balloon mayprovide a relatively large surface area contact. While examples hereinrefer to dilating the ethmoid infundibulum (EI) in order to improveaccess to the maxillary ostium (MO), to thereby use dilation cathetersystem (10) to dilate the maxillary ostium (MO), it should be understoodthat there may be other reasons to dilate the ethmoid infundibulum (EI).By way of example only, dilating the ethmoid infundibulum (EI) maysimply provide patency to improve flow of air/mucus/etc. into and out ofthe maxillary sinus. Dilating the ethmoid infundibulum (EI) may alsofacilitate the removal of obstructions from within the ethmoidinfundibulum (EI). Other potential reasons for dilating the ethmoidinfundibulum (EI) will be apparent to those of ordinary skill in the artin view of the teachings herein.

FIG. 7 shows an exemplary dilation instrument (80) that may be used togently move the uncinate process (UP), to thereby dilate the ethmoidinfundibulum (EI) and improve access to (and visualization of) themaxillary ostium (MO). Dilation instrument (80) of this examplecomprises a handpiece (82), and a shaft (84) extending distally fromhandpiece (82). At least a portion of shaft (84) may be malleable orsemi-rigid. Shaft (84) includes a curved probe tip (86). The curvatureand length of probe tip (86) are selected to enable curved probe tip(86) to be positioned around the uncinate process (UP) and into theethmoid infundibulum (EI). A dilator (88) is disposed about curved probetip (86) and is operable to transition between an inflated state and anon-inflated state. Dilator (88) is thus similar to dilator (22)described above. However, in the present example dilator (88) isinflatable to a larger cross-sectional area than dilator (22), sincedilator (22) is configured to dilate smaller passageways (e.g., sinusostia) than dilator (88). Dilator (88) is formed of a compliant materialsuch that its shape will conform to the shape of anatomical structuresthat dilator (88) bears against when in an inflated state. By way ofexample only, dilator (88) may be formed of a thermoplastic elastomersuch as urethane, polyether block amide such as PEBAX® (by Arkema ofParis, France), Hytrel® (by E. I. du Pont de Nemours and Company ofWilmington, Del.), and/or any other suitable material(s). Dilator (88)is in fluid communication with a port (90) located at the proximal endof handpiece (82). Port (90) is configured to couple with a fluid source(e.g., a source of saline) via any suitable means. By way of exampleonly, port (90) may comprise a leur connector.

In an exemplary use, dilation instrument (80) is inserted into thepatient's nasal cavity and curved probe tip (86) is navigated around theuncinate process (UP) into the ethmoid infundibulum (EI). This may beaccomplished using direct vision, endoscope (60) described above, someother kind of endoscope, or some other means of visualization. Oncecurved probe tip (86) is appropriately positioned, fluid is communicatedto dilator (88) via port (90), such that dilator (88) transitions to aninflated state as shown in FIG. 8A. As dilator (88) inflates, dilator(88) dilates the ethmoid infundibulum (EI). It should be understood thatone or more of the anatomical structures around the ethmoid infundibulum(EI) may be moved by dilator (88) to provide this dilation. In someinstances, inflating dilator (88) moves the uncinate process (UP)inferiorly and/or anteriorly. In addition or in the alternative,inflating dilator (88) may move the middle turbinate (MT) medially. Inaddition or in the alternative, inflating dilator (88) may move ethmoidbulla (B) superiorly and/or posteriorly. Because dilator (88) is formedof a compliant material, it conforms to the shape of the uncinateprocess (UP), the middle turbinate (MT), and the ethmoid bulla (B), suchthat the contact between dilator (88) and the uncinate process (UP), themiddle turbinate (MT), and the ethmoid bulla (B) is over a maximumsurface area. This may reduce the risk of trauma to the uncinate process(UP), the middle turbinate (MT), and the ethmoid bulla (B) due toexpansion of dilator (88).

In the present example, after dilator (88) dilates the ethmoidinfundibulum (EI), the result is shown in FIG. 8B, where the passagewayprovided by the ethmoid infundibulum (EI) is significantly larger thanthe pre-dilation passageway shown in FIG. 6. This larger, dilatedpassageway provided by the ethmoid infundibulum (EI) enhances access toand visualization of the maxillary ostium (MO). In some instances, anadditional device may be installed to maintain the dilation of theethmoid infundibulum (EI). Various examples of such devices will bedescribed in greater detail below, while others will be apparent tothose of ordinary skill in the art in view of the teachings herein.

It should be understood that some versions of dilation instrument (80)may be inserted through guide catheter (30) or a variation thereof.Furthermore, dilation instrument (80) may be constructed as a variationof dilator catheter (20) (e.g., having a dilator (88) that is differentfrom dilator (22)). Dilation instrument (80) may also be configured toslide along a guidewire such as guidewire (50). Alternatively, dilationinstrument (80) may be used without any kind of guide catheter (30) orguidewire (50). In addition, dilation instrument (80) may be constructedand operable in accordance with at least some of the teachings of U.S.Pub. No. 2010/0030113, entitled “Paranasal Ostium Finder Devices andMethods,” published Feb. 4, 2010, the disclosure of which isincorporated by reference herein.

FIGS. 9A-10B show another exemplary dilation instrument (100) that maybe used to dilate nasal and paranasal structures. Dilation instrument(100) of the present example comprises a hollow rail (110) and a dilatorassembly (120) that translates along rail (110). The exterior of rail(110) presents a pair of inwardly extending tracks (118) along thelength of rail (110). Tracks (118) are configured to enable translationof dilator assembly (120) along rail (110) as will be described ingreater detail below. Rail (110) includes a radiused curved region (112)and a distally narrowing tapered region (114) distal to curved region(112). In some instances, the taper of tapered region (114) extendsalong at least part of the length of curved region (112). A ball tip(116) is positioned at the distal end of tapered region (114). Thecurvature of curved region (112) is selected to facilitate positioningof the distal end of dilation instrument (100) in a paranasal passageway(e.g., in the ethmoid infundibulum (EI), etc.). The configuration ofball tip (116) is atraumatic to reduce the risk of inadvertentlydamaging tissue while navigating dilation instrument (100) intoposition. It should also be understood that ball tip (116) may be usedfor atraumatic exploration of areas such as the frontal recess in apatient. The frontal recess may have several pathways, some of which are“dead ends” known as terminal recesses. Ball tip (116) may allow theoperator to assess whether a recess leads to other structures or is aterminal recess.

Dilator assembly (120) of the present example comprises an inflatabledilator (122) secured to a sled platform (124). In the present example,dilator (122) and sled platform (124) are located at an angular positionabout the longitudinal axis of rail (110) such that dilator (122) andsled platform (124) are on the inside of the curve defined by curvedregion (112). In some other versions, dilator (122) and sled platform(124) are oriented such that dilator (122) and sled platform (124) areon the outside of the curve defined by curved region (112).Alternatively, dilator (122) and sled platform (124) may be orientedsuch that dilator (122) and sled platform (124) are on a lateral side(e.g., 90 degrees from the inside/outside) of the curve defined bycurved region (112). Of course, any other orientation may be used. Sledplatform (124) includes a pair of guide blocks (130), though it shouldbe understood that any suitable number of guide blocks (130) may beused. As shown in FIGS. 10A-10B, guide blocks (130) include integralmale key elements (132) that project inwardly and are received in tracks(118). The disposition of key elements (132) in tracks (118) providesangular stability for platform (124) about the longitudinal axis of rail(110); yet enable platform (124) to freely slide longitudinally alongrail (110). Other suitable relationships between guide blocks (130) andrail (110) will be apparent to those of ordinary skill in the art inview of the teachings herein. For instance, while guide blocks (130) arepositioned on the exterior of rail (110) in the present example, itshould be understood that rail (110) and guide blocks (130) may bereadily modified to position guide blocks (130) within the interior ofrail (110).

Dilator (122) is in fluid communication with a conduit (140), whichextends through the hollow interior of rail (110). Dilator (122) may beformed of a compliant material just like dilator (88) described above.In some versions, a distal portion of conduit (140) bends transverselyand passes through platform (124) to reach conduit (140). In some otherversions, the distal end of conduit (140) includes an angled fittingthat couples conduit (140) with dilator (122). Rail (110) defines alongitudinally extending slot that enables conduit (140) or the fittingto pass from the interior of rail (110) to platform (124). Conduit (140)translates with dilator assembly (120) as dilator assembly (120)translates along rail (110). It should be understood that a variety offeatures may be used to drive translation of dilator assembly (120)along rail (110). By way of example only, platform (124) may be securedto a drive tube that is slidably disposed about the exterior of rail(110), such that platform (124) may be translated by translating thedrive tube relative to rail (110). As yet another merely illustrativeexample, platform (124) may be driven by a push/pull cable feature.Other suitable ways in which dilator assembly (120) may be translatedalong rail (110) will be apparent to those of ordinary skill in the artin view of the teachings herein.

In an exemplary use, dilation instrument (100) is initially positionedsuch that tapered region (114) is located within the desired anatomicalregion while dilator assembly (120) is in the retracted position andnon-inflated state shown in FIGS. 9A and 10A. By way of example only,dilation instrument (100) may be positioned such that tip (116) islocated within the ethmoid infundibulum (EI), just medial to themaxillary ostium (MO), with curved region (112) reaching around theuncinate process (UP). Then, dilator assembly (120) is advanced distallyalong rail (110) until dilator (122) is positioned adjacent to theuncinate process (UP). Platform (124) is compliant enough to traversecurved region (112) while remaining engaged with rail (110) and withoutdeforming rail (110) during such traversal. Some versions of platform(124) may include transversely extending ribs or other reinforcementfeatures that enable such deformation without promoting deformation ofplatform (124) about the longitudinal axis of rail (110).

After dilator assembly (120) has been advanced to a suitable distalposition, fluid (e.g., saline) is then communicated through conduit(140) to inflate dilator (122) to the inflated state shown in FIGS. 9Band 10B. The expansion of dilator (122) drives the uncinate process (UP)medially and/or inferiorly, thereby dilating the ethmoid infundibulum(EI). Due to the general rigidity of rail (110) and the presence ofplatform (124), the only forces exerted on the patient's anatomy byinflation of dilator (122) are on the uncinate process (UP). In otherwords, the rigidity of rail (110) and platform (124) provides amechanical ground that absorbs forces exerted by dilator (122) towardthe ethmoid bulla (B) and the middle turbinate (MT), such that neitherdilator (122) nor rail (110) bears against the ethmoid bulla (B) or themiddle turbinate (MT) during inflation of dilator (122). Platform (124)thus constrains expansion of dilator (122) to only a restricted angularrange (i.e., less than 360°) about the longitudinal axis of rail (100).While at least a portion of dilation instrument (100) may incidentallycontact the ethmoid bulla (B) or the middle turbinate (MT) duringinflation of dilator (122), those anatomical structures are not moved orremodeled by inflation of dilator (122). The forces exerted on thepatient's anatomy by the inflation of dilator are thus asymmetricrelative to the longitudinal axis of rail (110). After dilator (122) hasbeen inflated to dilate the ethmoid infundibulum (EI), the fluid may beremoved from dilator (122) and dilation instrument (100) may be removedfrom the patient. In some instances, dilation assembly (120) isretracted to a proximal position along rail (110) before rail (110) ispulled out of the patient. In some other instances, rail (110) is pulledout of the patient while dilation assembly (120) remains at a distalposition along rail (110).

As noted above, dilation instrument (100) may be used in various otherprocedures and in various other parts of a patient's anatomy. By way ofexample only, dilation instrument (100) may be used to dilate thefrontal recess (FR) that extends between the ethmoid infundibulum (EI)or adjacent spaces and the frontal paranasal sinus. While dilationinstrument (100) is discussed herein in the context of dilating thefrontal recess (FR), it should be understood that dilation instrument(100) and variations thereof may be readily used in various otherprocedures and locations. By way of example only, dilation instrument(100) may be used to dilate structures within the frontal recess, whichis the passageway that courses past the ethmoid bulla (B) and up to thefrontal sinus. Pneumatized air cells may form part of the boundaries ofthe frontal recess, such that it may be advantageous to be able toperform selective dilatation in that area so as to choose which of thesecells to apply force to. In particular, dilation instrument (100) of thepresent example allows for selective remodeling of an agger nasi aircell (typically found anterior to the frontal recess (FR)) while notapplying force to a suprabullar air cell (which typically lies posteriorto the frontal recess (FR)). Alternatively, with the orientation ofdilator assembly (120) or dilation-constraining element rotatedapproximately 180 degrees about the longitudinal axis of rail (110), asuprabullar air cell can be selectively remodeled while not applyingforce to the agger nasi cell. Other procedures and locations in whichdilation instrument (100) may be used will be apparent to those ofordinary skill in the art in view of the teachings herein.

In addition to having dilator assembly (120) positioned at any suitableangular orientation about the longitudinal axis of rail (110), it shouldbe understood that dilator (122) may be advanced to (and dilated at) anysuitable location along the length of rail (110). In other words, insome uses dilator assembly (120) stops advancing at curved region (112)or proximal to curved region (112), with dilator (122) then beinginflated at that point. In some alternative versions of dilationinstrument (100), dilator assembly (120) does not translate along rail(110) and is simply fixed in position at the distal end of rail (110).Various suitable ways in which dilation instrument (100) may beconfigured and used will be apparent to those of ordinary skill in theart in view of the teachings herein.

FIGS. 11-16 show another exemplary dilation instrument (700) that may beused to dilate nasal and paranasal structures. By way of example only,dilation instrument (700) may be used in the same procedures and partsof a patient's anatomy as identified above with respect to dilationinstrument (100). Other suitable same procedures and parts of apatient's anatomy where dilation instrument (700) may be used will beapparent to those of ordinary skill in the art in view of the teachingsherein. Dilation instrument (700) of the present example comprises ahandle (710), a rigid guide catheter (720), a guidewire (730), and adilation catheter (740). Handle (710) is provided so that a surgeon orother operator can controllably position dilation instrument (700) andapply grounding forces to dilation instrument (700) in order to counterforces that are encountered during dilation and to thus maintain astable position of dilation instrument (700) relative to the head of thepatient. Handle (710) comprises a plurality of slidable actuators (712)and a plurality of laterally extending gripping members (714). Actuators(712) are configured to slide along the body of handle (710) to permit auser to independently advance guidewire (730), dilation catheter (740),and/or other components relative to handle (710). Gripping members (714)are configured to fit between and adjacent to a user's fingers tothereby permit a user to firmly grasp handle (710) with a single hand.Alternatively, handle (710) may have any other suitable configuration.For instance, in some other versions, handle (710) may be configuredsimilarly to dilation catheter system (10) described above, wherevarious functional components also serve as a grip for an operator.Other suitable forms that handle (710) may take will be apparent tothose of ordinary skill in the art in view of the teachings herein.

Guide catheter (720) extends distally from handle (720). In the presentexample, guide catheter (720) is rigid, though in some other versions atleast a portion of guide catheter (720) may be flexible or semi-rigid.Guide catheter (720) has a lumen (not shown) extending axiallytherethrough with an open distal end (722). As will be described ingreater detail below, guidewire (730) may be slidably disposed withinthe lumen of guide catheter (720) such that the operator may advanceguidewire (730) axially through open distal end (722). In the presentexample, guide catheter (720) comprises a curved portion (724) near opendistal end (722) of guide catheter (720). In some versions, curvedportion (724) may be more or less curved, or omitted entirely, with sucha curve being adapted for dilation of the drainage pathway of aparticular paranasal sinus. By way of example only, a set of instruments(700) may have guide catheters (720) with curved portions (724)presenting different curvatures, such that the operator may select aparticular instrument (700) from the set with a curved portions (724)having a curvature that is particularly suited for the anatomicallocation in which instrument (700) will be used. Various suitablecurvatures that curved portion (724) may have will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

As described above, guidewire (730) is slidably disposed within thelumen of guide catheter (720). Guidewire (730), like guidewire (50)discussed above, may have an illuminating tip such that guidewire (730)may provide transillumination through regions of a patient's head. Inaddition or in the alternative, guidewire (730) may include one or moreelectromagnetic tracking features, a distal camera assembly, a distalultrasonic transducer, and/or any other suitable feature(s), includingcombinations thereof. In the present example, the distal end ofguidewire (730) comprises a ball tip (732). As will be described ingreater detail below, ball tip (732) may enable guidewire (730) to beused to like a conventional “sinus seeker” instrument to atraumaticallyprobe and/or investigate anatomical regions in a patient's head. In someversions, ball tip (732) has an outer diameter that is greater than theinner diameter of the lumen of guide catheter (720), such that ball tip(732) is prevented from being pulled proximally into distal end (722) ofguide catheter (720).

In the present example, guidewire (730) is coupled with an actuator(712) of handle assembly (710), such that actuator (712) may betranslated relative to handle assembly (710) to thereby translateguidewire (730) relative to guide catheter (720). This may enable theoperator to selectively translate guidewire (730) between a proximalposition (in which ball tip (732) is in contact with distal end (722) ofguide catheter (720)) and various distal positions (in which ball tip(732) is spaced distally from distal end (722) of guide catheter (720)).It should also be understood that an actuator (712) may include arotating element to further provide selective rotation of guidewire(730), about the longitudinal axis of guidewire (730), relative to guidecatheter (720). By way of example only, one or more actuators (712) thatare associated with guidewire (730) may be provided in accordance withat least some of the teachings of U.S. Pub. No. 2012/0071856, entitled“Medical Device and Method for Treatment of a Sinus Opening.” publishedMar. 22, 2012, the disclosure of which is incorporated by referenceherein. Likewise, various other features of instrument (700) may beconstructed and operable in accordance with at least some of theteachings of U.S. Pub. No. 2012/0071856.

Dilation catheter (740) is positioned coaxially relative to guidecatheter (720) such that dilation catheter (740) wraps around guidecatheter (720) like a sheath. As can best be seen in FIG. 12, dilationcatheter (740) comprises a catheter portion (742), a balloon dilator(744), and two retaining rings (746) that are positioned on each end ofballoon dilator (744). Catheter portion (742) extends distally fromhandle (710), through balloon dilator (744), and terminates at an opendistal end (743) positioned distally of balloon dilator (744). Catheterportion (742) defines a lumen (not shown) that permits guide catheter(720) to extend through the length of catheter portion (742). Catheterportion (742) also provides an inflation lumen (not shown) in fluidcommunication with balloon dilator (744), such that the inflation lumenmay be used to inflate balloon dilator (744) as will be described ingreater detail below. At least part of catheter portion (742) isflexible in the present example, such that catheter portion (742) may betranslated relative to guide catheter (720) to selectively drive balloondilator (744) between a proximal position (where balloon dilator (744)is positioned along and/or proximal to curved portion (724)) and adistal position (where balloon dilator (744) is positioned along and/ordistal to curved portion (724)). In the present example, one of theactuators (712) of handle (710) is operable to translate dilationcatheter (740) relative to guide catheter (720). By way of example only,one or more actuators (712) that are associated with dilation catheter(740) may be provided in accordance with at least some of the teachingsof U.S. Pub. No. 2012/0071856, entitled “Medical Device and Method forTreatment of a Sinus Opening,” published Mar. 22, 2012, the disclosureof which is incorporated by reference herein. It should also beunderstood that handle (710) may include an actuator (712) or otherfeature that enables the operator to rotate dilation catheter (740)about the longitudinal axis of guide catheter (720), thereby enablingthe operator to selectively position balloon dilator (744) at a desiredangular position about the longitudinal axis of guide catheter (720).

Balloon dilator (744) is positioned about catheter portion (742) nearthe open distal end (743) of catheter portion (742). Balloon dilator(744) is comprised of a semi-compliant material in the present example.In some other versions, balloon dilator (744) may be compliant ornon-compliant and may comprise any other suitable material such aspolyamid (Nylon), polyurethane, polydimethyl siloxane (Silicone),polyester, polyolefin, etc. Various suitable materials and combinationsof materials that may be used to form balloon dilator (744) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

Retaining rings (746) are positioned at each end of balloon dilator(744) and completely encircle catheter portion (742) and each end ofballoon dilator (744). In the present example, retaining rings (746) arefixedly secured to balloon dilator (744). In some other versions,retaining rings (746) may be at least partially slidable relative toballoon dilator (744) and/or catheter portion (742). Retaining rings(746) are connected to each other by a plurality of inelastic retainingwires (748) that extend from one retaining ring (746) to the other.Retaining wires (748) may be grouped together to restrict the inflationof balloon dilator (744) in a given lateral direction, as will bedescribed in greater detail below. As can be seen in FIGS. 15 and 16,retaining wires (748) are connected to each other to form a web-likeconfiguration. In other words, retaining wires (748) are arranged suchthat there are a plurality (e.g., three) of longitudinally extendingretaining wires (748) and a plurality (e.g., three) of transverselyextending retaining wires (748). The transversely extending retainingwires (748) are secured to the longitudinally extending retaining wires(748). Such a web-like configuration may maintain retaining wires (748)in a fixed relationship relative to each other or at least restrict thedegree to which the longitudinally extending retaining wires (748) maylaterally separate from each other. Although a particular fixedrelationship is shown, it should be understood that retaining wires(748) may be arranged in any suitable manner. It should also beunderstood that connections between retaining wires (748) may be omittedsuch that retaining wires are independent of each other.

In the present example, both retaining rings (746) and retaining wires(748) are comprised of a metallic material such that they may be weldedtogether. In some other versions, retaining rings (746) and retainingwires (748) may be comprised of a polymer or other plastic and are fusedor otherwise bonded together (e.g., with an adhesive, etc.). It shouldalso be understood that retaining rings (746) and retaining wires (748)may be dissimilar materials. Of course, retaining rings (746) andretaining wires (748) may be of any other suitable material and may becombined by any other suitable means as will be apparent to those ofordinary skill in the art in view of the teachings herein. In someversions, retaining wires (748) are laterally flexible yetlongitudinally inelastic such that the length of each retaining wire(748) is fixed. In some other versions, retaining wires (748) are rigid.In either case, retaining wires (748) cooperate with retaining rings(746) to restrict inflation of balloon dilator (744) on the side ofballoon dilator (744) at which wires (748) are positioned. Balloondilator (744) thus has a constrained side (or region) and annon-constrained side (or region), such that balloon dilator (744) willinflate asymmetrically about the longitudinal axis of dilation catheter(740). In other words, wires (748) constrains expansion of balloondilator (744) to only a restricted angular range (i.e., less than 360°)about the longitudinal axis of guide catheter (720).

Various other suitable forms that retaining wires (748) may take, aswell as various other suitable properties retaining wires (748) mayhave, will be apparent to those of ordinary skill in the art in view ofthe teachings herein. It should also be understood that wires (748) arejust one example. Any other suitable kinds of structures may be used toconstrain expansion of balloon dilator (744) on one side of balloondilator (744).

In an exemplary use, dilation instrument (700) is initially positionedsuch that open distal end (722) of guide catheter (720) is locatedwithin the desired anatomical region while dilation catheter (740) is ina retracted position and non-inflated state shown in FIG. 11. By way ofexample only, dilation instrument (700) may be positioned such that opendistal end (722) of guide catheter (720) is located within the frontalrecess, near an agger nasi air cell and suprabullar air cell. Suchpositioning of the guide catheter (720) may be accomplished usingtransillumination provided by guidewire (730). In addition or in thealternative, ball tip (732) may be positioned at or distal to distal end(722) of guide catheter (720) such that guide catheter (720) may be usedas a seeker tip. Of course, in either case endoscopic visualization maybe used to assist with positioning of guide catheter (720).

Once guide catheter (720) is positioned at the desired position withinthe patient, dilation catheter (740) is advanced distally along guidecatheter (720) until balloon dilator (744) is positioned adjacent to thestructure that is to be dilated. Catheter portion (742) and balloondilator (744) are compliant enough to traverse curved portion (724) ofguide catheter (720). In one merely illustrative example, balloondilator (744) may be positioned adjacent to an agger nasi air cell andan suprabullar air cell. Of course, balloon dilator (744) may bepositioned in any desired position as will be apparent to those ofordinary skill in the art in view of the teachings herein. It shouldalso be understood that some versions may permit rotation of dilationcatheter (740) about guide catheter (720), such that the non-constrainedside of balloon dilator (744) may be selectively located at a desiredangular position about the longitudinal axis of guide catheter (720).

After dilation catheter (740) has been advanced to a suitable distalposition, fluid (e.g., saline) is then communicated through theinflation lumen to inflate balloon dilator (744) to the inflated stateshown in FIGS. 13-16. As can be seen, rigid wires (748) are configuredto prevent the expansion of balloon dilator (744) in a particulardirection or range of directions. Rigid wires (748) further act totransfer force from the restricted side of balloon dilator (744) tohandle (710) via guide catheter (720) such that an operator may directthe force of expansion toward a structure that is intended to beremodeled. Thus, the expansion of balloon dilator (744) may reconstructone anatomical structure while leaving another adjacent anatomicalstructure unaffected. For instance, when balloon dilator (744) ispositioned within the frontal recess, with the expanding portion ofballoon dilator (744) anterior to the frontal recess, balloon dilator(744) may reconstruct the agger nasi air cell while leaving an adjacentsuprabullar air cell intact. Alternatively, dilation instrument (700)(or dilation catheter (740)) may be rotated 180° such that the expandingportion of balloon dilator (744) is posterior to the frontal recess toreconstruct the suprabullar air cell while leaving the adjacent aggernasi air cell intact. In other words, balloon dilator (744) isconfigured to selectively apply a force to an anatomical structure onone side of balloon dilator (744) while not applying force to theanatomical structure on the other side of balloon dilator (744).

In some versions, dilation instrument (700) may include other structuresthat may be used to assist in mechanically grounding handle (710) suchthat the expansion of balloon dilator (744) causes remodeling of onlythe anatomical structure that is on the expandable side of balloondilator (744). In other words, mechanical grounding may prevent theexpansion of balloon dilator (744) from remodeling the anatomicalstructure that is on the same side of balloon dilator (744) as wires(748) (i.e., the constrained side of balloon dilator (744)). Suchmechanical grounding may, for example, include an external structurethat is mounted to a patient table, a procedure chair, or any othersuitable structure.

As noted above, dilation instrument (700) may be used in various otherprocedures and in various other parts of a patient's anatomy (e.g., insome other outflow tract of a patient's paranasal sinus). In addition tohaving dilation catheter (740) positioned at any suitable angularorientation about the longitudinal axis of guide catheter (720), itshould be understood that balloon dilator (744) may be advanced to (anddilated at) any suitable location along the length of guide catheter(720). In other words, in some uses dilation catheter (740) stopsadvancing at curved portion (724) or proximal to curved portion (724),with balloon dilator (744) then being inflated at that point. In somealternative versions of dilation instrument (700), dilation catheter(740) does not translate along guide catheter (720) and is simply fixedin position at the distal end of guide catheter (720). Various othersuitable ways in which dilation instrument (700) may be configured andused will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

IV. Exemplary Support for Uncinate Process

As noted above, dilation instruments (80, 100, 700) may be used todilate the ethmoid infundibulum (EI) by moving the uncinate process(UP), to dilate the frontal recess (FR), and/or to dilate otheranatomical structures. In some instances, this process may effectivelyremodel the uncinate process (UP) and/or other anatomical structure(s)such that the ethmoid infundibulum (EI) remains dilated for at least adesired period of time. However, the uncinate process (UP) and/or otheranatomical structure(s) may eventually move back to a previous positionand/or other conditions may eventually arise where the ethmoidinfundibulum (EI) is no longer effectively dilated. This may or may notbe undesirable. In instances where it is desirable to maintain dilationof the ethmoid infundibulum (EI), one or more implantable devices may beinstalled at or near the ethmoid infundibulum (EI) to maintain thedilated state. Various examples of such implantable devices aredescribed in greater detail below while others will be apparent to thoseof ordinary skill in the art in view of the teachings herein. It shouldbe understood that the implantable devices described below may be usedafter either of the dilation instruments (80, 100, 700) described abovehave been used to dilate the ethmoid infundibulum (EI); or after someother instrument has been used to dilate the ethmoid infundibulum (EI).Furthermore, various suitable ways in which the implantable devicesdescribed below may be positioned and installed will be apparent tothose of ordinary skill in the art in view of the teachings herein. Forinstance, any of the below described implantable devices may beinstalled using visualization from endoscope (60) or some other form ofvisualization. It should also be understood that, while the examplesdescribed below are provided in the context of the ethmoid infundibulum(EI), the devices and techniques described below may be readily adaptedfor use in various other parts of a patient's anatomy.

FIG. 17 shows an exemplary wedge (200) that may be used to maintaindilation of the ethmoid infundibulum (EI). Wedge (200) of this examplecomprises a pair of legs (202) that are joined together at a vertex(204), thereby forming a wedge angle. In the present example, wedge(200) is oriented such that vertex (204) points generally mediallytoward the middle turbinate (MT). In some other versions, wedge (200) isoriented such that vertex (204) points toward the maxillary ostium (MO).Alternatively, wedge (200) may be positioned such that vertex (204)points anteriorly, posteriorly, superiorly, inferiorily, or any suitablecombination thereof. The free end of each leg (202) includes arespective barbed anchor (206). As shown, one anchor (206) is secured inthe ethmoid bulla (B) in this example while the other anchor is securedin the uncinate process (UP). Alternatively, anchors (206) may besecured elsewhere. As yet another merely illustrative variation, vertex(204) may include an anchor in addition to or in lieu of legs (202)having anchors (206). By way of example only, vertex (204) may have ananchor that is secured in the middle turbinate (MT). Other suitablearrangements will be apparent to those of ordinary skill in the art inview of the teachings herein.

Wedge (200) may be formed of a rigid material. Alternatively, wedge(200) may be formed of a malleable material. As yet another merelyillustrative alternative, wedge (200) may be formed of a resilientmaterial that is biased to assume a position like the one shown in FIG.17; yet that compresses to facilitate insertion of wedge (200) into thefinal installation position. In still other versions, wedge (200) isformed by a pair of rigid legs that pivot at or near vertex (204). Forinstance, a mechanical hinge or a living hinge may be located at or nearvertex (204). Such a hinge may be resiliently biased or may beselectively locked/unlocked to enable installation of wedge (200). Itshould be understood that wedge (200) may be installed at any suitableposition along the length of the uncinate process (UP), and that theconfiguration of wedge (200) should not obstruct the fluid path throughthe ethmoid infundibulum (EI). It should also be understood that wedge(200) may be formed of a bioabsorbable material, if desired. By way ofexample only, wedge (200) may be formed of polylactic acid (PLA),polydioxanone (PDS), polycaprolactone, and/or any other suitablematerial(s).

FIG. 18 shows an exemplary mesh scaffold (300) that may be in used tomaintain dilation of the ethmoid infundibulum (EI). Scaffold (300) maybe installed within the ethmoid infundibulum (EI) such that scaffold(300) is interposed between the ethmoid bulla (B) and the uncinateprocess (UP). In some versions, scaffold (300) is formed of a resilientmaterial (e.g., nitinol, etc.), such that scaffold (300) is held in acompressed state until it reaches the installation site where it is thenreleased to expand outwardly. This outward bias of scaffold (300) mayboth hold the ethmoid infundibulum (EI) in the dilated state andeffectively secure scaffold to the ethmoid bulla (B) and the uncinateprocess (UP) (e.g., due to mucosa tissue protruding through the openingsdefined between the wires forming the mesh of scaffold (300), etc.). Insome other versions, scaffold (300) is malleable such that scaffold(300) is actively expanded to reach the state shown in FIG. 18. By wayof example only, scaffold (300) may be positioned about the exterior ofa dilator while scaffold is in a non-expanded state and while thedilator is in the non-inflated state. The dilator and scaffold (300) maythen be positioned in the ethmoid infundibulum (EI), wherein the dilatormay then be inflated to dilate the ethmoid infundibulum (EI). Scaffold(300) may expand with the dilator in the ethmoid infundibulum (EI). Thedilator may then be deflated and removed from the patient, leavingscaffold (300) in place in an expanded state within the ethmoidinfundibulum (EI). Other suitable configurations, properties, andinstallation techniques for scaffold (300) will be apparent to those ofordinary skill in the art in view of the teachings herein.

FIG. 19 shows an exemplary tether (400) that may be used to maintaindilation of the ethmoid infundibulum (EI). Tether (400) of this examplecomprises an elongate body (402) that has hook anchors (404) at eachend. One hook anchor (404) is secured to the inferior side of theuncinate process (UP) while the other hook anchor (404) is secured tothe medial side of the lateral wall (LW). Tether body (402) isconfigured to maintain tension between anchors (404), thereby holdingthe uncinate process (UP) in the position shown in FIG. 19, to therebymaintain dilation of the ethmoid infundibulum (EI). By way of exampleonly, tether (400) may comprise polyester or some other biocompatibletextile that does not stretch. As another merely illustrative example,tether (400) may comprise a metal and/or plastic material. Othersuitable materials and configurations that may be incorporated intotether (400) will be apparent to those of ordinary skill in the art inview of the teachings herein.

In some instances, tether (400) is installed while a separate dilator isused to move and temporarily hold the uncinate process (UP) into theposition shown in FIG. 19. In some other instances, tether (400) is usedto move the uncinate process (UP) into the position shown in FIG. 19.For instance, a hook anchor (404) may first be secured in the inferiorside of the uncinate process (UP) or on any other region of the uncinateprocess (UP). The operator may then pull on tether body (402) to movethe uncinate process (UP) medially and/or anteriorly. While holding themoved position of the uncinate process (UP), the operator may thensecure the other hook anchor (404) the medial side of the lateral wall(LW). Other suitable ways in which tether (400) may be installed will beapparent to those of ordinary skill in the art in view of the teachingsherein.

FIG. 20 shows another exemplary positioning device (500) that may beused to maintain dilation of the ethmoid infundibulum (EI). Device (500)is configured for installation in a position where device (500) willbear medially on the middle turbinate (MT) while bearing anteriorly onthe uncinate process (UP). Device (500) of this example comprises aresilient mesh body (502). It should be understood that a mesh is justone example, and that any other suitable kind of structure may be usedto form body (502). It should also be understood that body (502) may bemalleable instead of being resilient. Other suitable configurations andproperties for device (500) will be apparent to those of ordinary skillin the art in view of the teachings herein. Similarly, various suitableways in which device (500) may be installed will be apparent to those ofordinary skill in the art in view of the teachings herein.

V. Exemplary Infundibular Illumination Device

As noted above, the natural anatomy of the ethmoid infundibulum (EI) maymake it difficult to access the maxillary ostium (MO). The anatomy ofthe ethmoid infundibulum (EI) may also make it difficult to effectivelyilluminate and visualize the ethmoid infundibulum (EI) (e.g., to therebyvisualize the maxillary ostium (MO)). By way of example only, it may bedesirable to illuminate and visualize the ethmoid infundibulum (EI) andmaxillary ostium (MO) in order to gauge the location, irritation, size,and other characteristics of the maxillary ostium (MO). It may also bedesirable to illuminate and visualize the ethmoid infundibulum (EI) andmaxillary ostium (MO) in order to position dilation catheter system (10)or some other device to dilate the maxillary ostium (MO). Furthermore,it may be desirable to illuminate and visualize the ethmoid infundibulum(EI) to search for pouches, dead ends, tissue qualities that couldinfluence a therapeutic decision, etc., within the ethmoid infundibulum(EI) itself.

The anatomy of some patients may enable illumination/viewing of theethmoid infundibulum (EI) (and perhaps even the maxillary ostium (MO))simply using an apparatus such as endoscope (60) described above.However, in some other patients, endoscope (60) may not providesufficient illumination/visualization of the ethmoid infundibulum (EI)and/or the maxillary ostium (MO). It may therefore be desirable toprovide an additional illumination and/or visualization device thatprovides enhanced illumination/viewing capabilities within the ethmoidinfundibulum (EI). Examples of such devices are described in greaterdetail below, while still other examples will be apparent to those ofordinary skill in the art in view of the teachings herein. While theexemplary devices are described in the context of illuminating/viewingthe ethmoid infundibulum (EI), it should be understood the devicesdescribed below may be readily used in various other regions of thenasal cavity.

FIGS. 21A-21B show an exemplary infundibular illuminator (600) that isoperable to illuminate the ethmoid infundibulum (EI). Illuminator (600)of this example comprises an outer tube (610) and an inner tube (620)that is slidably disposed in outer tube (610). Outer tube (610) isformed of a rigid or semi-rigid material (e.g., a metal, plastic, and/orother material). Outer tube (610) has a radiused curved region (612)that terminates in distal end (614). In the present example, curvedregion (612) is defined by a constant radius sweeping along an arc angle(Θ-theta), beginning at the proximal portion of curved region (612) andending at distal end (614). In some versions, the arc angle (Θ-theta) isat least 90 degrees. In some such versions, the arc angle (Θ-theta) isat least 135 degrees. In some such versions, the arc angle (Θ-theta) isat least 180 degrees. Curved region (612) may be rigid, semi-rigid, orresilient. For instance, at least a portion of curved region (612) maybe resiliently biased to assume the position shown in FIG. 21A.

Inner tube (620) has a distal tip (622) and at least one internaloptical fiber (624). Distal tip (622) of the present example has awedge-like profile but is atraumatic. Thus, when distal tip (622) isadvanced into a narrowly defined ethmoid infundibulum (EI), distal tip(622) may assist in driving the ethmoid bulla (B) and uncinate process(UP) apart without causing damage to either anatomical structure. Insome instances, illuminator (600) is used in conjunction with one of thesupport devices discussed above for maintaining dilation of the ethmoidinfundibulum (EI), such that tip (622) may not need to drive apart theethmoid bulla (B) and uncinate process (UP). Optical fiber (624) extendsalong the length of inner tube (620) and is coupled with a light source(630) via an optical cable (640). Light source (630) may comprise aconventional external light source. In some other versions, light source(630) is integrated into illuminator (600). In some such versions,illuminator (600) also includes an integral power source (e.g., abattery) to power light source (630). Light source (630) may comprise anLED, laser, or any other suitable source of light. Light source (630)may also be configured to generate light having a specific wavelengthassociated with specific types of normal and/or diseased tissue, suchthat the light from light source (630) will make such tissue visiblystand out.

Cable (640) and fiber (624) are configured to transmit light from lightsource (630) to tip (622). Tip (622) comprises a transparent ortranslucent material that is configured to project light from fiber(624). Thus, tip (622) may illuminate the ethmoid infundibulum (EI) whentip (622) is positioned within the ethmoid infundibulum (EI). Inaddition to tip (622) providing illumination, other portions of innertube (620) may also provide illumination. For instance, inner tube (620)may include a plurality of transversely extending light pipes locatedproximal to tip (622).

With outer tube (610) being held in position, inner tube (620) may beadvanced distally relative to outer tube (610) (as shown in FIG. 21B) toextend tip (622) further into the ethmoid infundibulum (EI), therebyilluminating further depths of the ethmoid infundibulum (EI). Inaddition, inner tube (620) of the present example is steerable, suchthat the portion of inner tube (620) extending distal to distal end(614) may be selectively deflected away from an axis that isperpendicular to the opening defined by distal end (614). This mayfurther enhance control of illumination by illuminator (600) within theethmoid infundibulum (EI). Various suitable features that may be used toprovide advancement of inner tube (620) relative to outer tube (610)will be apparent to those of ordinary skill in the art in view of theteachings herein. Similarly, various suitable features that may be usedto provide deflection of inner tube (620) away from an axis that isperpendicular to the opening defined by distal end (614) will beapparent to those of ordinary skill in the art in view of the teachingsherein. It should be noted that advaceability and steerability of innertube (620) are merely optional. For instance, some versions ofilluminator (600) may lack inner tube (620), such that tip (622) isunitary with distal end (614) of outer tube (610). In addition, someversions of inner tube (620) may be advanceable but not steerable. Asyet another merely illustrative variation, a light emitting featurewithin inner tube (620) may be steerable while inner tube (620) itselfis not steerable. For instance, a light emitting feature within innertube (620) may be pivotable within inner tube (620).

It should be understood that curved region (612) may enable illuminator(600) to be used as a retractor. By way of example only, illuminator(600) may be positioned such that tip (622) is used to initially drivethe ethmoid bulla (B) and uncinate process (UP) apart. With tip (622)positioned within the ethmoid infundibulum (EI), and with curved region(612) engaging the uncinate process (UP), illuminator (600) may begently pulled inferiorly to displace the uncinate process (UP) and openthe ethmoid infundibulum (EI) wider. Illuminator (600) may thus be usedas an uncinate process (UP) retractor. Outer tube (610) may include asoft outer material (e.g., rubber, foam, etc.) to minimize trauma to theuncinate process (UP) when illuminator (600) is used as a retractor.While using outer tube (610) to hold the uncinate process (UP) in aretracted position, the operator may manipulate tip (622) to illuminatethe ethmoid infundibulum (EI). The combination of uncinate process (UP)retraction and ethmoid infundibulum (EI) illumination provided byilluminator (600) may greatly enhance visualization of the ethmoidinfundibulum (EI). In some instances, this may enable the operator toview the ethmoid infundibulum (EI) (and in some cases the maxillaryostium (MO)) using endoscope (60) while using illuminator (600) as aretractor and as a source of light. It should also be understood thatilluminator (600) may itself include an optical assembly that enablesviewing through illuminator (600). Various other suitable components,configurations, and methods of operating illuminator (600) will beapparent to those of ordinary skill in the art in view of the teachingsherein.

VI. Miscellaneous

It should be understood that any of the examples described herein mayinclude various other features in addition to or in lieu of thosedescribed above. By way of example only, any of the examples describedherein may also include one or more of the various features disclosed inany of the various references that are incorporated by reference herein.

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions described above may be designed to be disposed of after asingle use, or they can be designed to be used multiple times. Versionsmay, in either or both cases, be reconditioned for reuse after at leastone use. Reconditioning may include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, someversions of the device may be disassembled, and any number of theparticular pieces or parts of the device may be selectively replaced orremoved in any combination. Upon cleaning and/or replacement ofparticular parts, some versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a userimmediately prior to a procedure. Those skilled in the art willappreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be sterilizedbefore and/or after a procedure. In one sterilization technique, thedevice is placed in a closed and sealed container, such as a plastic orTYVEK bag. The container and device may then be placed in a field ofradiation that can penetrate the container, such as gamma radiation,x-rays, or high-energy electrons. The radiation may kill bacteria on thedevice and in the container. The sterilized device may then be stored inthe sterile container for later use. A device may also be sterilizedusing any other technique known in the art, including but not limited tobeta or gamma radiation, ethylene oxide, or steam.

Having shown and described various embodiments of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, embodiments, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I/We claim:
 1. An apparatus comprising: (a) an elongate member, whereinthe elongate member defines a longitudinal axis; and (b) a dilationassembly slidable relative to the elongate member, wherein the dilationassembly comprises: (i) an inflatable dilator, wherein the inflatabledilator is operable to expand from a non-inflated state to an inflatedstate, wherein the inflatable dilator is configured to slide along apath defined by the elongate member, (ii) a constraining member securedto the inflatable dilator, wherein the constraining member is positionedand configured to restrict expansion of the inflatable dilator in onedirection transverse to the longitudinal axis while permitting expansionof the inflatable dilator in another direction transverse to thelongitudinal axis, and (iii) a conduit in fluid communication with thedilator.
 2. The apparatus of claim 1, wherein the elongate membercomprises a rail.
 3. The apparatus of claim 1, wherein the elongatemember comprises a catheter.
 4. The apparatus of claim 1, wherein theconstraining member comprises a set of wires.
 5. The apparatus of claim4, wherein the set of wires comprises a set of longitudinally extendingwires and a set of laterally extending wires.
 6. The apparatus of claim5, wherein the laterally extending wires are secured to thelongitudinally extending wires such that the laterally extending wiresand the longitudinally extending wires together form a web-likeconfiguration.
 7. The apparatus of claim 4, wherein the constrainingmember further comprises: (A) a proximal ring, wherein the proximal ringis located at a proximal end of the inflatable dilator, and (B) a distalring, wherein the distal ring is located at a distal end of theinflatable dilator, wherein the set of wires extend between the proximalring and the distal ring.
 8. The apparatus of claim 1, wherein theconstraining member comprises a platform.
 9. The apparatus of claim 1,wherein the constraining member provides a constrained region of theinflatable dilator and a non-constrained region of the inflatabledilator, wherein the constrained region is located on one lateral sideof the longitudinal axis, wherein the non-constrained region is locatedon another lateral side of the longitudinal axis, such that thelongitudinal axis is laterally interposed between the constrained regionand the non-constrained region.
 10. The apparatus of claim 1, whereinthe constraining member provides a constrained region of the inflatabledilator and a non-constrained region of the inflatable dilator, whereinthe constrained region is located on one lateral side of thelongitudinal axis, wherein the non-constrained region is located on thesame side of the longitudinal axis further outward from the longitudinalaxis, such that the constrained region is laterally interposed betweenthe longitudinal axis and the non-constrained region.
 11. The apparatusof claim 1, wherein the elongate member has a curved region, wherein thelongitudinal axis bends along the curved region.
 12. The apparatus ofclaim 1, wherein the elongate member has a tapered region.
 13. Theapparatus of claim 1, wherein the elongate member has a ball tip. 14.The apparatus of claim 1, further comprising a guidewire slidablydisposed in the elongate member.
 15. The apparatus of claim 12, whereinthe guidewire has a ball tip.
 16. A method of using a dilationinstrument to dilate a drainage passageway of a paranasal sinus in ahuman patient, wherein the dilation instrument comprises a guide featureand a dilation feature, wherein the guide feature defines a longitudinalaxis, wherein the dilation feature is slidable relative to the guidefeature along the longitudinal axis, the method comprising: (a)inserting the guide feature into the nostril of a patient; (b) advancingthe dilation feature along the guide feature to position the dilationfeature in a selected drainage passageway of a paranasal sinus in thepatient; and (c) expanding the dilation feature asymmetrically about thelongitudinal axis to remodel a first anatomical structure defining afirst portion of the drainage passageway without remodeling a secondanatomical structure defining a second portion of the drainagepassageway.
 17. The method of claim 16, wherein the drainage passagewaycomprises a frontal recess.
 18. The method of claim 17, wherein thefirst anatomical structure comprises an agger nasi air cell, wherein thesecond anatomical structure comprises a suprabullar air cell.
 19. Themethod of claim 16, wherein the act of expanding the dilation featureasymmetrically about the longitudinal axis comprises constraining anexterior portion of the dilation feature to prevent the constrainedexterior portion from expanding.
 20. An apparatus comprising: (a) aguide member, wherein the guide member defines a longitudinal axis; and(b) a dilation feature, wherein the dilation feature is slidablerelative to the guide member, wherein the dilation feature comprises:(i) an expandable dilator, and (ii) a deflection member, wherein thedeflection member is configured to direct the expandable dilator toexpand laterally from the longitudinal axis in only a restricted angularrange about the longitudinal axis, and wherein the deflection member andthe guide member are configured to cooperate to provide a mechanicalgrounding to exert force in the restricted angular range.